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Not yet recruitingNCT07920887ACTIVATE-HFpEFUpdated Nov 6, 2026

A Study of Bimagrumab in Participants With HFpEF

A Phase 2 interventional study of Bimagrumab and Placebo in Heart Failure, Diastolic, Diastolic Heart Failure and Heart Failure, Normal Ejection Fraction, sponsored by Eli Lilly and Company. Not yet recruiting at 9 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
540
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will look at how bimagrumab affects adults who have a type of heart failure called HFpEF (heart failure with preserved ejection fraction), where the heart pumps normally but does not fill with blood as well as it should. Participation in the study will last about 76 weeks.

02

Conditions studied

  • Heart Failure, Diastolic
  • Diastolic Heart Failure
  • Heart Failure, Normal Ejection Fraction
  • Heart Failure, Preserved Ejection Fraction

Keywords

  • Muscle
  • Sarcopenia
  • Physical function
  • Adipose tissue
03

In context

Heart Failure, Diastolic

199 studies on the registry are indexed under Heart Failure, Diastolic; 44 are open to participants now.

This study's planned enrollment of 540 is above the median of 48 across 139 interventional studies indexed under Heart Failure, Diastolic.

Browse Heart Failure, Diastolic studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have Class II to III heart failure
  • Have (LVEF) ≥ 50%
  • KCCQ-CSS ≤ 80
  • 6MWD must be all of the following:

    • ≥100 and ≤ 450 meters (m) based on average of 2 tests conducted at screening visit, AND
    • ≥ 100 and ≤ 450 m on 1 test at randomization visit, AND
    • \< 20% change from average qualifying 6MWD obtained at screening
  • Have documented evidence of at least one of the following:

    • Heart failure event
    • Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide)
    • Left atrium enlargement
    • Elevated filling pressure
  • Stable dose of heart failure medications
  • (BMI) ≥ 23 kilograms per meter squared (kg/m²)

Exclusion criteria

Exclusion Criteria:

  • Heart failure hospitalization \< 4 weeks before screening
  • Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery/intervention, stroke or in past 12 weeks prior to screening, or unstable angina pectoris in past 4 weeks prior to screening or during screening
  • Type 1 diabetes
  • (HbA1c) ≥ 9.5%
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
540 participants (estimated)

Study arms

  • Experimental
    Bimagrumab Dose 1

    Participants will receive bimagrumab subcutaneously (SC)

    Drug: Bimagrumab

  • Experimental
    Bimagrumab Dose 2

    Participants will receive bimagrumab SC

    Drug: Bimagrumab

  • Placebo comparator
    Placebo 1

    Participants will receive placebo SC

    Drug: Placebo

  • Placebo comparator
    Placebo 2

    Participants will receive placebo SC

    Drug: Placebo

Interventions

  • Administered SC

    Also known as: LY3985863

  • DrugPlacebo

    Administered SC

06

What researchers measure

Primary outcomes

  1. Change from Baseline in the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS)

    Time frame: Baseline, Week 52

Secondary outcomes

  1. Change from Baseline in the 6-Minute Walk Test Distance (6MWD)

    Time frame: Baseline, Week 52

  2. Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP)

    Time frame: Baseline, Week 52

  3. Percentage of Participants who Achieve Responder Status for KCCQ-CSS

    Time frame: Week 52

  4. Percentage of Participants who Achieve Responder Status for 6-Minute Walk Test Distance

    Time frame: Week 52

  5. Change from Baseline in Early Transmitral Inflow Velocity / Early Diastolic Mitral Annular Velocity (E/e')

    Time frame: Baseline, Week 52

  6. Change from Baseline in Total Body Lean Mass

    Time frame: Baseline, Week 52

07

Study locations

9 sites
  • InvivoCure LLC
    Van Nuys, California 91405, United States
    • Rodney Samaan · Principal investigator
  • Amavita Research Services, LLC
    North Miami Beach, Florida 33169, United States
    • Pedro Martinez-Clark · Principal investigator
  • Dharma PA d/b/a Southwest Family Medicine Associates
    Dallas, Texas 75235, United States
    • Chrisette Dharma · Principal investigator
  • Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika
    Budapest, H-1122, Hungary
    • Bela Merkely · Principal investigator
  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Sant' Anna e San Sebastiano di Caserta
    Caserta, 81100, Italy
    • · Contact0823 23207475
    • Paolo Calabro · Principal investigator
  • A.O. Ordine Mauriziano di Torino
    Torino, 10128, Italy
    • Giuseppe Musumeci · Principal investigator
  • Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II
    Krakow, 31-202, Poland
    • Pawel Rubis · Principal investigator
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
    Wroclaw, 50-556, Poland
    • Joanna Szachniewicz · Principal investigator
  • 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
    Wroclaw, 50-981, Poland
    • Bartosz Krakowiak · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07920887
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jul 2029 (estimated)
Completion
Nov 2029 (estimated)
Last update
Nov 6, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Bimagrumab

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